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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03992495
Other study ID # N-20180063_Sub-project_3
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 20, 2019
Est. completion date January 2021

Study information

Verified date June 2019
Source Aalborg University
Contact Steffan W Christensen, PhD
Phone 99408889
Email stc@hst.aau.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study investigates the effect of exercise on pain sensitivity in ongoing neck pain patients compared to a healthy control group.


Description:

Increased pain sensitivity is a common finding in neck pain patients when compared to healthy controls. Although most studies favor exercise as an intervention, the specific effect on pain sensitivity is still debated. This study will investigate the effect of exercise on pain sensitivity in neck pain patients compared to healthy controls


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 46
Est. completion date January 2021
Est. primary completion date October 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Healthy participants

- Pain free healthy participants

- Able to speak, read and understand Danish and English

Exclusion Criteria: - Healthy participants

- Pain from the neck or shoulder area during the past 6 months

- Experience of delayed onset muscle soreness (DOMS) during the week leading up to the test session

- Former surgery in neck or shoulder

- Current or previous chronic or recurrent pain condition

- Pregnancy

- Drug addiction defined as the use of cannabis, opioids or other drugs

- Previous neurologic, musculoskeletal or mental illnesses

- Regular use of analgesics

- Abnormally disrupted sleep in the last 24 hours preceding the experiment

- Lack of ability to cooperate

Inclusion Criteria: - Neck pain population

- Self reported neck pain lasting three months or longer.

- Able to speak, read and understand Danish and English

- Reduced/painful active range of motion of the head and/or painful reaction to palpation of the neck at the time of inclusion

Exclusion Criteria: - Neck pain population

- Shoulder pain during arm movements

- Experience of DOMS during the week leading up to the test session

- Former surgery in neck or shoulder

- Current or previous chronic or recurrent pain condition other than neck pain

- Pregnancy

- Drug addiction defined as the use of cannabis, opioids or other drugs

- Previous neurologic, musculoskeletal or mental illnesses

- Abnormally disrupted sleep in the 24 hours preceding the experiment

- Lack of ability to cooperate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
All participants will be exposed to aerobic/strengthening exercises

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University

Outcome

Type Measure Description Time frame Safety issue
Other Change in body movements Head repositioning accuracy will be tested using a clinical test in a seated position. Participants will turn their head to end of range in from a neutral position with their eyes closed and return to the start position again. The difference between start and end position will be recorded. Standing balance will be assessed by recording the time (seconds) a tandem stance can be maintained. Baseline, 6 weeks, 12 weeks
Primary Change in pain sensitivity Pain sensitivity will be estimated by determining the pressure pain threshold (PPT) on the neck before and after exercise Baseline, 6 weeks, 12 weeks
Secondary Change in perceived pain Pain will be scored using a scale from 0-10 with 0 being no pain and 10 being worst imaginable pain and by drawing perceived painful areas on a body charts Baseline, 6 weeks, 12 weeks
Secondary Change in disability Disability will be estimated by scoring the Neck Disability Index (NDI) questionnaire. The questionnaire is designed to help express how neck pain affects your ability to manage everyday activities.(Domains: pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping, recreation). Higher score = high level of disability Baseline, 6 weeks, 12 weeks
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